VERTEX Nitinol Staple System

K182943 · Nvision Biomedical Technologies, LLC · JDR · Apr 4, 2019 · Orthopedic

Device Facts

• Record ID: K182943
• Device Name: VERTEX Nitinol Staple System
• Applicant: Nvision Biomedical Technologies, LLC
• Product Code: JDR · Orthopedic
• Decision Date: Apr 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VERTEX Nitinol Staple System is indicated for bone fragments and osteotomy fixation and joint arthrodesis of the hand or foot.

Device Story

The VERTEX Nitinol Staple System consists of superelastic nickel-titanium (nitinol) alloy bone staples and associated surgical instruments. Used by orthopedic surgeons in clinical settings for foot and ankle pathologies, the staples provide compression across bone fragments, osteotomies, or arthrodesis sites. The device functions via the superelastic properties of nitinol, which exerts continuous compressive force on bone tissue to facilitate healing. The system is provided as a range of sizes to accommodate different anatomical requirements. It does not require cold storage or heating for activation. The surgeon selects the appropriate staple size and uses the provided instrumentation to implant the device, which then maintains fixation through its mechanical design and material properties.

Clinical Evidence

No clinical data provided. Safety and efficacy were demonstrated through bench testing, including static bending, bending fatigue, and pullout testing per ASTM F564; cyclic potentiodynamic polarization testing per ASTM F2129; and bend and free recovery testing per ASTM F2082.

Technological Characteristics

Low-profile bone staples constructed from superelastic nickel-titanium (nitinol) alloy. Features toothed legs for fixation. Testing conducted per ASTM F564 (mechanical), ASTM F2129 (corrosion), and ASTM F2082 (recovery). No software or electronic components.

Indications for Use

Indicated for bone fragments, osteotomy fixation, and joint arthrodesis of the hand or foot in patients requiring bone fixation.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Novastep Arcad Compressive Osteosynthesis Staple (K142111)
• New Deal (Integra) Uni-Clip Staple (K011716)
• BioMedical Enterprises, Inc Speed Staple (K142292)

Reference Devices

• Uni-Clip Staple (K991482)
• Uni-Clip Staple (K061594)

Submission Summary (Full Text)

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Nvision Biomedical Technologies, LLC % Jeffrey Brittan Consultant Watershed Ideas Foundry 1815 Aston Ave., Suite 106 Carlsbad, California 92008

Re: K182943

Trade/Device Name: VERTEX Nitinol Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: October 22, 2018 Received: October 23, 2018

Dear Jeffrey Brittan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

April 4, 2019

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Daniel S. Ramsey -S 2019.04.04 14:34:48 -04'00'

FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182943

Device Name VERTEX™ Nitinol Staple System

#### Indications for Use (Describe)

The VERTEX Nitinol Staple System is indicated for bone fragments and osteotomy fixation and joint arthrodesis of the hand or foot.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Nvision Biomedical Technologies. The logo features a stylized "N" with horizontal lines emanating from the left side, followed by the word "VISION" in a bold, sans-serif font. Below the main logo, the words "biomedical technologies" are written in a smaller, italicized font, suggesting the company's focus on the biomedical field.

## 510(k) Summary

## DATE PREPARED

April 2, 2019

#### MANUFACTURER AND 510(k) OWNER

Nvision Biomedical Technologies, Inc. 4754 Shavano Oak, Suite 101 San Antonio, TX 78249, USA Telephone: [phone] Fax: [phone] Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance

## REPRESENTATIVE/CONSULTANT

Jeffrey Brittan Watershed Idea Foundry Telephone: [phone] Email: jeffbrittan(@watershedideas.com

## PROPRIETARY NAME OF SUBJECT DEVICE

VERTEXTM Nitinol Staple System

COMMON NAME Bone Staple

#### DEVICE CLASSIFICATION Staple, Fixation, Bone

(Classification Regulations: 21 CFR 888.3030, Product Codes: JDR, Class: II)

#### PREMARKET REVIEW

ODE/DOD/Joint and Fixation Devices (JFDB2) Orthopedic Panel

#### INDICATIONS FOR USE

The VERTEX Nitinol Staple System is indicated for bone fragments and osteotomy fixation and joint arthrodesis of the hand or foot.

#### DEVICE DESCRIPTION

The VERTEX Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The VERTEX bone staples are made from superelastic nitinol that does not require cold storage or heating.

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Image /page/4/Picture/0 description: The image contains the logo for Nvision biomedical technologies. The logo has a stylized "N" with a series of short, parallel lines extending from the left side of the "N", giving the impression of movement or technology. Below the main logo, the words "biomedical technologies" are written in a smaller, sans-serif font.

## PREDICATE DEVICE IDENTIFICATION

| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---------------|--------------------------------------------------|-------------------|
| K142111 | Novastep Arcad Compressive Osteosynthesis Staple | ✓ |
| K011716 | New Deal (Integra) Uni-Clip Staple* | |
| K142292 | BioMedical Enterprises, Inc Speed Staple | |

The VERTEX Nitinol Staple System is substantially equivalent to the following predicates:

* Additional Uni-Clip Staple clearances include K991482 and K061594

#### SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the VERTEX Nitinol Staple System. The following tests were performed to demonstrate safety based on recognized consensus standards and current industry practice:

- Static bending, bending fatigue, and pullout (per ASTM F564)
- . Cyclic potentiodynamic polarization testing (per ASTM F2129)
- . Bend and free recovery (BFR) testing (per ASTM F2082)

The results of these tests, as well as engineering analysis of device characteristics, indicate that the VERTEX Nitinol Staple System is substantially equivalent to the predicate devices.

## EQUIVALENCE TO PREDICATE DEVICES

Nvision believes that the VERTEX Nitinol Staple System is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design, similar dimensions, and uses similar or identical materials as the devices cleared in K142111, K011716, and K142292. The subject device also has the same intended use, as well as similar technological characteristics (low profile bone staples with toothed legs in a range of sizes) as these predicates. The Indications for Use are equivalent and these technological characteristics have undergone testing and engineering analysis to ensure the device is as safe and effective as the predicates.

#### CONCLUSION

Based on the testing performed, including static bending fatigue, and pullout, cvclic potentiodynamic polarization, bend and free recovery as well as engineering analysis of device characteristics. it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed VERTEX Nitinol Staple System are assessed to be substantially equivalent to the predicate devices.